[Hinews] Celltrion, a South Korean biopharmaceutical company, has launched its autoimmune disease treatment Aptozma (tocilizumab) in the U.S., marking a significant step in its global market strategy. The drug, initially introduced as an intravenous (IV) formulation, will soon be followed by a subcutaneous (SC) version, expanding its accessibility to patients.

Aptozma is priced approximately 35% lower than its originator drug at wholesale acquisition cost (WAC), a strategic move by Celltrion to balance affordability with profitability. The biosimilar works by inhibiting interleukin-6 (IL-6), a cytokine that drives inflammation, and has received U.S. Food and Drug Administration approval for the same indications as the originator, including rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis, and COVID-19.

A notable early achievement is Aptozma’s inclusion as a preferred drug on the formulary of Blue Cross Blue Shield (BCBS) of Minnesota, part of a major U.S. insurance network covering over 100 million members nationwide. This designation signals strong potential for broader adoption across other BCBS plans, enhancing the drug’s market reach.

Celltrion's Aptozma IV formulation (Photo courtesy of Celltrion)
Celltrion's Aptozma IV formulation (Photo courtesy of Celltrion)


Celltrion is actively negotiating with major U.S. pharmacy benefit managers (PBMs) to further secure coverage. The company is also leveraging its existing autoimmune drug portfolio, including infliximab (Zymfentra), adalimumab (Yuflyma), and ustekinumab (Steqeyma), to create marketing synergies and strengthen its position in the U.S. biosimilar market.
To support Aptozma’s market entry, Celltrion is expanding its U.S. sales force, particularly targeting specialists in rheumatoid arthritis. The forthcoming SC formulation is expected to broaden distribution channels, enabling availability in pharmacies alongside hospitals, thus offering tailored treatment options for patients.

Thomas Nusbickel, chief commercial officer of Celltrion USA, emphasized the company’s direct-to-market expertise: “Drawing on our experience with prior products, we’re focused on rapidly establishing Aptozma in the U.S. market. Our goal is to enhance treatment access while providing meaningful options for healthcare providers and patients.”

Aptozma’s originator drug, Actemra, generated global sales of approximately $3.2 billion last year, with more than half from the U.S. market. Celltrion’s competitive pricing and strategic expansion signal a bold push to capture a share of this lucrative segment.

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